Acute Myeloid Leukemia Clinical Trial
Official title:
Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Diagnosed CD7 positive relapsed/refractory acute leukemia. 2. Age 12-65 years. 3. Eastern Cooperative Oncology Group (ECOG) score 0-2. 4. CD7 on leukemia is >30% positive detected with flow cytometry. 5. Patients with left ventricular ejection fraction = 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL. Exclusion Criteria: 1. Patients are pregnant or lactating 2. Patients with congenital immunodeficiency. 3. Patients with central nervous system leukemia. 4. Patients with uncontrolled active infection. 5. Patients with active hepatitis B or hepatitis C infection. 6. Patients with HIV infection. 7. Patients with atrial or venous thrombosis or embolism. 8. Patients with myo-infarction or severe arrythmia in the recent 6 months. 9. Other comorbidities that investigators considered not suitable for this study. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | (Select) |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 12 months | |
Secondary | Overall response rate (ORR) | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | 2 years | |
Secondary | Cumulative incidence of relapse(CIR) | time from the date of achievement of a remission until the date of relapse. | 2 years | |
Secondary | the duration of CAR T-cells in vivo | the time of CAR-T cells' persistence in blood and the copies of CAR-T cells | 2 years |
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